Check-Cap Ltd. is a clinical-stage medical diagnostics company advancing the development of C-Scan, the first and only preparation-free capsule-based screening method for the prevention of colorectal cancer through the detection of precancerous polyps, announced positive final results from its recently completed post-CE approval study evaluating the clinical performance and safety of the C-Scan system.
A multi-center, open-label, home monitoring, prospective study was designed to determine the performance characteristics of Check-Cap’s capsule-based screening test, the C-Scan system, for detecting pre-cancerous polyps compared with a fecal immunochemical test (FIT), a commonly used non-invasive colorectal cancer screening test; in each case using colonoscopy as the reference method.
The study included 90 evaluable patients who either had known polyps or were considered to be of average risk. Each participant ingested a C-Scan capsule and also underwent FIT and a comparative colonoscopy performed by independent gastroenterologists, who were blinded to the corresponding test’s results. The C-Scan clinical evaluation was obtained using the evaluable patient population implementing a gender-based motility analysis and the results of both C-Scan and FIT were compared to colonoscopy.
Targeted primary efficacy endpoint of the study was sensitivity (ability to correctly identify patients with polyps) and specificity (ability to correctly identify patients with lack of polyps) of the C-Scan system compared to FIT in detecting subjects with polyps ≥ 10mm. The results demonstrate that C-Scan achieved a sensitivity of 76% (p=0.0005) in patients with polyps ≥ 10mm, while FIT achieved a sensitivity of 29% (p=0.005) in patients with polyps ≥ 10mm. C-Scan achieved a specialty of 82% in all patients while FIT achieves a specificity of 96% (p=0.0005) in patients with polyps ≥ 10mm, while FIT achieved a specificity of 96% in all patients.
Principal Investigator Comments
Nadir Arber, MD, MSc, MHA, Professor of Internal Medicine and Gastroenterology, and Head of Health Promotion Center and Integrated Cancer Center at the Tel-Aviv Sourasky Medical Center. He stated, according to New Kerala, that the final results from the post-CE approval study confirm the potential clinical value of the C-Scan system. The results offer an advancement in the detection of larger polyps, generally considered to have higher potential for malignant transformation. There is a great unmet need for a patient-friendly and preparation-free screening option that can detect polyps in the colon before they become cancerous. Although colorectal cancer can be prevented through detection of precancerous polyps, screening adherence remains low due to the bowel preparation, sedation and invasiveness associated with present-day screening methods. Dr. Arber is encouraged by C-Scan’s potential to reduce the global incidence of colorectal cancer.
New York Study
Check-Cap is conducting a United States pilot study to evaluate the safety, usability and subject compliance of the C-Scan system at the New York University of Medicine and Mayo Clinic. The lead investigator is Seth Gross, NYU Langone.Source: newKerala.com